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FDA Panel Recommends Low-T Drugs Only for Geniune Medical Conditions

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On September 17, 2014, the FDA convened an advisory panel meeting to review the safety and efficacy of testosterone replacement products like AndroGel and Testim. The panel, according to the New York Times and other media outlets, made some key recommendations as a result of the meeting.

Panel Makes New Recommendations

Prescriptions for testosterone replacement drugs are increasing. Reuters reported that in 2013, “2.3 million men received a prescription for testosterone, up from 1.3 million in 2010.” The FDA approved testosterone replacement products only for men with actual hypogonadism—low testosterone caused by a medical condition. But a 2013 study found that a quarter of the men who were taking the drugs were not tested for low testosterone, and that “most men did not have clear evidence of a potential indication for ART [androgen replacement therapy].”

As a result of this trend—and because of recent studies showing a link between testosterone replacement therapy and increased risk of heart attack and stroke—the FDA panel recommended:

• Change the labels on testosterone replacement drugs to indicate they are meant only for men with genuine hypogonadism—to hopefully reduce prescriptions written for men with vague symptoms like low energy and reduced libido.
• Require drug makers to conduct additional tests on the drugs to evaluate their risk of heart attack and stroke.

Panel Hopes to Counteract Manufacturer Advertising

If the FDA follows the panel’s recommendations, they may counteract the broad marketing campaigns implemented by testosterone replacement drug manufacturers. Advertisements for the products have suggested men experiencing symptoms like fatigue, sagging muscles, and reduced libido—all symptoms that could be simply a result of aging—are the result of dwindling testosterone levels.

Many men, as a result, ended up asking their physicians for prescriptions, more in the hopes of achieving an anti-aging result more than to treat an actual medical condition. “The whole idea is to try to rein in the inappropriate advertising and use of these drugs,” panel member Dr. Michael Domanski, director of heart failure research at Mount Sinai School of Medicine, told the New York Times.

Though doctors will still be allowed to prescribe testosterone off-label if they choose to do so, manufacturers will no longer be able to advertise the drugs for anything but a genuine medical condition. Insurance companies may also adjust available payments for the medications.

The overpromotion of drugs like AndroGel and Testim is one of the reasons many men have filed testosterone lawsuits, claiming that companies led men to believe they needed the drug when they didn’t, while downplaying the potential risks.

Testosterone Lawsuits Increasing

The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal testosterone replacement lawsuits in the Northern District of Illinois on June 6, 2014. Court documents revealed in August 2014 that over 200 claims had been filed there.